Principal Investigator(s)

Details

Protocol No. VICCMEL1398

Open Date: 05/23/2014

Staging: Phase II

Age Group:
Adults

Scope: National

Objective: To assess the intracranial response (IR) of subjects with centrally confirmed BRAF V600E-mutation positive melanoma that has metastasized to the
brain without symptoms and have not undergone prior local therapy for brain metastases (Cohort A).

Disease Sites:
Neuro-Oncology; Melanoma

Therapies:
Molecular Targeted Agents / Immunotherapy / Biologics

Drugs:
Dabrafenib; Trametinib

Participating Institutions:
Vanderbilt University

National Clinical Trial ID: NCT02039947

Secondary Protocol No:
BRF117277

Description

Participants are being asked to take part in this study because they have been diagnosed with melanoma with metastases to the brain.
The purpose of this study is to evaluate the safety and how well the combination of dabrafenib and trametinib works in patients with melanoma with metastases to the brain.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria: • ECOG Performance Status range of 0-2 • Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R. • May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma. • Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.Exclusion Criteria: • Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular signal-regulated kinase inhibitor. • Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe. • Treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe. • Any presence of leptomeningeal disease or any parenchymal brain metastasis • History of another malignancy, some exceptions may apply. • A history or evidence of cardiovascular risk- specific criteria have to be met • A history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment•specific criteria have to be met.